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Written Confirmations for export of Active Substances manufactured in the UK Post Brexit

"Written Confirmations for export of Active Substances manufactured in the UK"

This guidance covers the conditions to be implemented for GMP documentation, for a third country (such as the UK would become) when exporting Active Substances to the EEA.

  • Written Confirmations will be generated for UK Active Substance manufacturers whether they intend to export Active Substances or not, they will automatically become available for download from the MHRA website.

A Written Confirmation confirms that, for a third country exporting Active Substances to the EEA:

  • the standards of Good Manufacturing Practice (GMP) are equivalent to those in the EU/EEA
  • the manufacturing plant is subject to regular inspections (which may be both announced and unannounced)
  • significant non-compliance events would be communicated to the EEA without delay
For further details please refer to the full MHRA guidance here